Technical Field
The embodiments described herein relate to automated systems for designing and manufacturing patient-specific orthopedic devices, such as implants and instrumentation, based on data, such as imaging data, representing an existing joint.
Description of the Related Art
Personalized medicine is one of the fastest growing trends in the healthcare industry. While this trend has mainly been seen in the drug sector, medical device manufacturers have also recognized the benefits of individualizing their products to meet the needs of different patient groups. The orthopedic implant manufacturers have recently launched implants optimized for different genders or geographies, or combining patient-specific instruments with standardized implants. However, these are not truly personalized, patient-specific or patient-matched approaches. Technological advances now allow for the design and manufacture of implants and associated instrumentation optimized for a specific individual. Such implants fall on a spectrum from, e.g., implants that are based on one or two aspects or dimensions of a patient's anatomy (such as a width of a bone, a location of a defect, etc.) to implants that are designed to conform entirely to that patient's anatomy and/or to replicate the patient's kinematics.
One example of such patient-specific or patient-matched technology is the ConforMIS iFit® technology used in the iUni® (unicompartmental knee resurfacing implant) and iDuo® (dual compartmental knee resurfacing implant). This technology converts Computed Axial Tomography (“CT”) or Magnetic Resonance Imaging (“MRI”) scans into individualized, minimally invasive articular replacement systems capable of establishing normal articular shape and function in patients with osteoarthritis. By starting with imaging data, the approach results in implants that conform to bone or cartilage, and reduce the need for invasive tissue resection. The implant is made to fit the patient rather than the reverse. By designing devices that conform to portions of the patient's anatomy, the implants allow the surgeon to resurface rather than replace the joint, providing for far more tissue preservation, a reduction in surgical trauma, and a simplified technique.
The image-to-implant process begins with the patient having a medical image such as a CT or MRI scan, which can be done on commonly available machines, using a standardized protocol that ensures the data needed to design the implant is captured properly. The image data is then combined with computer-aided design (CAD) methods to generate a patient-specific model of the knee from which a patient-specific implant and/or patient-specific instrumentation can be designed and manufactured. The electronic design file created during this process is used to fabricate the patient-specific implant and custom instrumentation, which is a process that takes approximately four to six weeks.
The development and manufacture time associated with all types of patient specific devices could be significantly reduced if some or all aspects of the design and manufacture process were fully automated or more fully automated. Automation of some or all aspects of the process, including, without limitation, imaging, diagnosis, surgical planning, instrumentation design, implant design, manufacture, quality systems and distribution could result in, among other advantages, faster and less costly production, which could result in patient's being able to have surgery sooner and at a lower cost. Additionally, such systems could improve productivity of designers, which would have several advantages such as improving profitability of manufacturing such implants. Further, such systems would both directly and indirectly improve the quality of such implants by, example, providing defined rules to ensure patient-specific implant designs meet specification, and also indirectly by improving the cost effectiveness of skilled designers, which makes the technically skilled employees found in more developed countries such as the United States more economically competitive and thereby reducing the impetus to outsource such production to countries with less technically skilled but cheaper labor that may result in reduced quality in the design process.